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Evaluation of the Effectiveness of a Quality Improvement Intervention

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ClinicalTrials.gov Identifier: NCT04278612
Recruitment Status : Completed
First Posted : February 20, 2020
Last Update Posted : February 20, 2020
Sponsor:
Collaborators:
UNICEF
Institute for Healthcare Improvement
Information provided by (Responsible Party):
Christiane Horwood, University of KwaZulu

Study Description
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Brief Summary:
This rigorous evaluation demonstrated that implementation of a time-limited quality improvement strategy effectively improved coverage of some components of an integrated maternal and child health service in a complex health environment, but we were unable to achieve the changes needed to provide a comprehensive package of care for mothers and children.

Condition or disease Intervention/treatment Phase
Maternal and Child Health Other: Quality improvement intervention to strengthen health service provision Not Applicable

Detailed Description:

Background: Despite policies and guidelines recommending integration of health services in South Africa, provision of maternal and child health services remains fragmented. This study evaluated a rapid, scaleable, quality improvement intervention to improve integration of maternal and child health and HIV services at a primary health level, in KwaZulu-Natal, South Africa.

Methods: A three-month intervention comprised of six quality improvement mentoring visits, learning sessions with clinic staff to share learnings, and a self-administered checklist aimed to assist health workers monitor and implement an integrated package of health services for mothers and children. The study evaluated 27 clinics in four sub-districts using a stepped-wedge design. Each sub-district received the intervention sequentially in a randomly selected order. Five waves of data collection were conducted in all participating clinics between December 2016-February 2017. A multi-level, mixed effects logistic regression was used to account for random cluster fixed time and group effects using Stata V13.1.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1438 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: The study evaluated 27 clinics in four sub-districts using a stepped-wedge design. Each sub-district received the intervention sequentially in a randomly selected order. Five waves of data collection were conducted in all participating clinics
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Evaluation of the Effectiveness of a Quality Improvement Intervention to Support Integration of Maternal, and Child and HIV Care in Primary Health Care Facilities in South Africa
Actual Study Start Date : January 18, 2016
Actual Primary Completion Date : February 5, 2017
Actual Study Completion Date : January 16, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention

Provision of comprehensive care including the following:

Baby:

Measure weight and length Plot on appropriate growth charts in Road to Health Card (RTHC) Discuss with mother about the growth of the baby Identification of malnutrition and appropriate management Age-appropriate nutrition counselling Immunisation Developmental screening Vitamin A supplementation Deworming HIV Care: If mother is HIV positive -

  • Polymerase chain reaction (PCR) test for the baby repeated at 10 weeks
  • Nevirapine for the baby for six weeks

Mother:

Cervical cancer screening Provide family planning Screening tuberculosis (TB) and sexually transmitted infections (STIs)

HIV Care:

  • HIV positive mothers - provide ART for the mother and adherence support
  • HIV negative mothers- HIV test every three months while breastfeeding
 Other: Quality improvement intervention to strengthen health service provision
Quality improvement intervention comprising of regular improvement meetings based at clinics.
Active Comparator: Control
Routine maternal and child care service delivery
 Other: Quality improvement intervention to strengthen health service provision
Quality improvement intervention comprising of regular improvement meetings based at clinics.


Outcome Measures
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Primary Outcome Measures :
  1. Quality of Maternal and Child Care [ Time Frame: 3 months ]
    Proportion of mother-baby pairs who received comprehensive care


Secondary Outcome Measures :
  1. Quality of Child Care [ Time Frame: 3 months ]
    Proportion of babies who receive growth monitoring services

  2. Quality of Maternal Care [ Time Frame: 3 months ]
    Proportion of mothers who receive feeding advice


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women who attended the clinic for maternal and child health care services.
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Women who attended the clinic for maternal and child health care services at 27 participating clinics from January 2016-February 2017.

Exclusion Criteria:

Women who did not attend the clinic for maternal and child health care services at 27 participating clinics from January 2016-February 2017.

Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Christiane Horwood, Senior Researcher, University of KwaZulu
ClinicalTrials.gov Identifier: NCT04278612    
Other Study ID Numbers: UNIP123
First Posted: February 20, 2020    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD will not be shared
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Anytime
Access Criteria: We are more than happy to share our study protocol, statistical analysis plan or informed consent with anyone who is interested.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Christiane Horwood, University of KwaZulu:
Quality improvement
Integrated care
Maternal health
Child health
HIV/AIDS
 South Africa
Growth Monitoring
Child Growth
Nutrition